Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Sublingual methadone for the management of cancer-related procedural pain in inpatients: a phase II multicentre, open label, feasibility study

Acronym

SLM INPT

Study hypothesis

The overall goal of this research is to evaluate the effectiveness of sublingual methadone for cancer-related breakthrough pain (onset to time of meaningful relief and the duration of the relief of breakthrough pain). The overall hypothesis is that sublingual methadone, once optimal dose has been reached, will pre-empt or relieve moderate to severe treatment-related, incident pain within five minutes in at least half of episodes evaluated.

The purpose of this phase II study is to determine the feasibility of the dose titration and assessment protocol in the inpatient population, in the clinical setting of preventing or managing breakthrough pain, before conducting an appropriately powered phase III study. Thus the primary purpose of this study is to determine the proportion of patients who are successfully titrated to an effective dose of sublingual methadone.

Study design

Primary study design

Secondary study design

Trial setting

Trial type

Treatment

Patient information sheet

Condition

Cancer-related breakthrough pain

Intervention

Sublingual methadone

Intervention type

Drug

Phase

Phase II

Drug names

Methadone

Primary outcome measure

The primary objective of this current phase II study is to demonstrate the feasibility of a novel model to assess sublingual methadone to relieve iatrogenic, treatment-related incident breakthrough pain.

Specific aspects of feasibility are:1. To demonstrate the feasibility of recruitment to a study for incident pain in the inpatient setting2. Feasibility of dose titration in the inpatient setting3. Feasibility of filling out the pain assessments4. Provide preliminary evidence of efficacy5. To provide further information to document safety of the model

Secondary outcome measures

1. To develop a model of pharmacokinetic (PK) or pharmacodynamic (PD) study of breakthrough pain2. To develop a research tool, the Breakthrough Pain Assessment Tool (BPAT)3. To demonstrate proof of concept, with half of patients obtaining meaningful pain reduction within five minutes of administration, when given the identified optimal dose

Overall trial start date

01/06/2006

Overall trial end date

31/12/2007

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Pain due to cancer or its treatment2. Controlled baseline pain3. Episodes of predictable, treatment-related pain every day that are 4/10 in severity or greater, last ten minutes or longer, or episodes of breakthrough pain not related to cancer treatment, and are responsive to short-acting oral opioids such as morphine or hydromorphone4. Able to hold a volume of 1.0 cc of water under the tongue for a two-minute period5. Able to provide written, informed consent6. Able to fill out the study forms, and must be an inpatient

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Severe underlying respiratory disease such that the investigator is wary about the risk of respiratory failure from modest doses of opioid2. Prior sensitivity to methadone3. Currently taking methadone4. Clinically unstable or a life expectancy of less than one month making completion of the trial unlikely5. Patients who do not have an understanding of English enough to provide written, informed consent

Sponsor details

Sponsor type

Website

Funders

Funder type

Charity

Funder name

Alberta Cancer Board (Canada) - Competition (ref: 4640)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Infrastructural support by Canadian Institutes of Health Research (CIHR) grant number: PET 69772 - we received funding for Difficult Pain Problems NET Grant. The monies received were to provide infrastructural support for research or network activities across Canada.